510(k) K162382

Smart Dongle Blood Glucose Monitoring System by Taidoc Technology Corporation — Product Code NBW

K162382 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "Smart Dongle Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on April 14, 2017. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Taidoc Technology Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2017
Date Received
August 24, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type